Sorafenib Combined With Aspirin to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma

NCT02748304 | Terminated

• 1 other identifier: Huashan 003
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  5 years

Secondary Outcomes (2)

• Disease free survival

  5 years

• Number of patients with treatment-related bleedings who use aspirin

  5 years

Study Arms (3)

control

PLACEBO COMPARATOR

just follow up after liver resection in HCC patients

Other: control

sorafenib

ACTIVE COMPARATOR

use sorafenib after liver resection in HCC patients

Drug: sorafenib

sorafenib and aspirin

ACTIVE COMPARATOR

use sorafenib and aspirin after liver resection in HCC patients

Drug: sorafenib; Drug: aspirin

Interventions

control OTHER

just follow up

control

sorafenib DRUG

sorafenib 400mg bid po

Also known as: sorafenib treatment

sorafenib; sorafenib and aspirin

aspirin DRUG

aspirin 100mg qd po

Also known as: aspirin treatment

sorafenib and aspirin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The characteristics of the treatment history:
• No sorafenib treatment history, no sorafenib allergies.
• No chemotherapy, radiotherapy and transcatheter arterial chemoembolization(TACE) treatment history before surgery.
• The characteristics of the tumor:
• The pathological results is hepatocellular carcinoma.
• Meet any of the following articles:
• Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number\>3,Tumor size\>8cm,Tumor margin is not clear and no complete capsule.
• With the embolus in Portal vein, hepatic vein or bile duct.
• Preoperative rupture or invasion the adjacent organs.
• The positive cut edge.
• Residual lesions showed by Postoperative digital subtraction angiography(DSA).
• Alpha fetoprotein(AFP) did not drop to normal range two months after surgery.
• The characteristics of the patients:
• The patient age was between 18-75.
• The American Society of Anesthesiologists(ASA）score was I-III.

You may not qualify if:

• Sorafenib treatment before surgery.
• Pregnant or lactating women.
• The Child-pugh score was B-C.
• Patients with other malignant tumor.
• Patients with mental illness.
• Patients participated in other clinical trials in last three months.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huashan hospital

Shanghai, 200040, China

Location

Related Publications (16)

• Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.

  PMID: 14667750 RESULT

• Sun HC, Tang ZY, Wang L, Qin LX, Ma ZC, Ye QH, Zhang BH, Qian YB, Wu ZQ, Fan J, Zhou XD, Zhou J, Qiu SJ, Shen YF. Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol. 2006 Jul;132(7):458-65. doi: 10.1007/s00432-006-0091-y. Epub 2006 Mar 24.

  PMID: 16557381 RESULT

• Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.

  PMID: 18477802 RESULT

• Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

  PMID: 18650514 RESULT

• Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.

  PMID: 19095497 RESULT

• De Simone P, Crocetti L, Pezzati D, Bargellini I, Ghinolfi D, Carrai P, Leonardi G, Della Pina C, Cioni D, Pollina L, Campani D, Bartolozzi C, Lencioni R, Filipponi F. Efficacy and safety of combination therapy with everolimus and sorafenib for recurrence of hepatocellular carcinoma after liver transplantation. Transplant Proc. 2014 Jan-Feb;46(1):241-4. doi: 10.1016/j.transproceed.2013.10.035.

  PMID: 24507059 RESULT

• Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

  PMID: 26361969 RESULT

• Gasic GJ, Gasic TB, Stewart CC. Antimetastatic effects associated with platelet reduction. Proc Natl Acad Sci U S A. 1968 Sep;61(1):46-52. doi: 10.1073/pnas.61.1.46. No abstract available.

  PMID: 5246932 RESULT

• Gasic GJ, Gasic TB, Murphy S. Anti-metastatic effect of aspirin. Lancet. 1972 Oct 28;2(7783):932-3. doi: 10.1016/s0140-6736(72)92581-0. No abstract available.

  PMID: 4116642 RESULT

• Rothwell PM, Wilson M, Elwin CE, Norrving B, Algra A, Warlow CP, Meade TW. Long-term effect of aspirin on colorectal cancer incidence and mortality: 20-year follow-up of five randomised trials. Lancet. 2010 Nov 20;376(9754):1741-50. doi: 10.1016/S0140-6736(10)61543-7. Epub 2010 Oct 21.

  PMID: 20970847 RESULT

• Rothwell PM, Fowkes FG, Belch JF, Ogawa H, Warlow CP, Meade TW. Effect of daily aspirin on long-term risk of death due to cancer: analysis of individual patient data from randomised trials. Lancet. 2011 Jan 1;377(9759):31-41. doi: 10.1016/S0140-6736(10)62110-1. Epub 2010 Dec 6.

  PMID: 21144578 RESULT

• Mahdi JG, Alkarrawi MA, Mahdi AJ, Bowen ID, Humam D. Calcium salicylate-mediated apoptosis in human HT-1080 fibrosarcoma cells. Cell Prolif. 2006 Aug;39(4):249-60. doi: 10.1111/j.1365-2184.2006.00390.x.

  PMID: 16872361 RESULT

• Saad-Hossne R, Prado RG, Hossne WS. Effects of acetylsalicylic acid and acetic acid solutions on VX2 liver carcinoma in rabbits. In vivo analysis. Acta Cir Bras. 2007 Jul-Aug;22(4):299-308. doi: 10.1590/s0102-86502007000400012.

  PMID: 17625669 RESULT

• Abiru S, Nakao K, Ichikawa T, Migita K, Shigeno M, Sakamoto M, Ishikawa H, Hamasaki K, Nakata K, Eguchi K. Aspirin and NS-398 inhibit hepatocyte growth factor-induced invasiveness of human hepatoma cells. Hepatology. 2002 May;35(5):1117-24. doi: 10.1053/jhep.2002.32676.

  PMID: 11981761 RESULT

• Zhang W, Sun HC, Wang WQ, Zhang QB, Zhuang PY, Xiong YQ, Zhu XD, Xu HX, Kong LQ, Wu WZ, Wang L, Song TQ, Li Q, Tang ZY. Sorafenib down-regulates expression of HTATIP2 to promote invasiveness and metastasis of orthotopic hepatocellular carcinoma tumors in mice. Gastroenterology. 2012 Dec;143(6):1641-1649.e5. doi: 10.1053/j.gastro.2012.08.032. Epub 2012 Aug 23.

  PMID: 22922424 RESULT

• Lu L, Sun HC, Zhang W, Chai ZT, Zhu XD, Kong LQ, Wang WQ, Zhang KZ, Zhang YY, Zhang QB, Ao JY, Li JQ, Wang L, Wu WZ, Tang ZY. Aspirin minimized the pro-metastasis effect of sorafenib and improved survival by up-regulating HTATIP2 in hepatocellular carcinoma. PLoS One. 2013 May 31;8(5):e65023. doi: 10.1371/journal.pone.0065023. Print 2013.

  PMID: 23741443 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; Aspirin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Salicylates; Hydroxybenzoates; Phenols

Study Officials

• Lunxiu Qin, MD

  Department of general surgery, Huashan hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the general surgery department, Huashan hospital

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 22, 2016
• Study Start: April 1, 2016
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CN (1)